Hospital Smallpox Vaccination Perspective

1. Hospital Smallpox Vaccination Perspective Dino P. Rumoro, D.O., F.A.C.E.P. Clinical Chairman Assistant Professor Department of Emergency Medicine January 10, 2003

2. Center of Excellence:Bioterrorism Preparedness Supported by a grant from the Chicago Department of Public Health

3. What You Must Be Asking Yourself: • Questions • Why?…Is this important • What?..Is the risk of an outbreak • What?..Is the risk of the vaccine • How?…Do I proceed • DO I PROCEED?

4. History of Bioterrorism • 6th Century B.C. • Solon of Athens poisoned water with skunk cabbage during the siege of Krissa • 184 B.C. • During a naval battle against King Eumenes of Pergamon, Hannibal hurled pots of snakes • 1346 • During the siege of Kaffa, the Tartar army catapulted its plague infected dead over the city walls

5. History of Bioterrorism • 15th Century • Pizarro gave South American natives clothing infected with smallpox • 1914-1917 • WWI: Germany allegedly tried to spread cholera in Italy and plague in St. Petersburg • 1936 • Unit 731 formed - Japanese biowarfare team responsible for thousands of deaths

6. History of Bioterrorism • 1941-1943 • US army develops biological agent R&D unit • 1960’s • Vietcong use fecally contaminated spear traps • 1978 • Bulgarian exile, Georgi Markov, dies after assassin injects ricin pellet from an umbrella • 1979 • USSR Military Compound 19 explodes and releases an agent that kills 40-1000 (anthrax)

7. Who is Manufacturing Bioweapons? • Iran, Iraq, Libya, Syria, North Korea, Taiwan, Israel, Egypt, Vietnam, Laos, Cuba, Bulgaria, India, South Korea, South Africa, China, Russia • (Based on a 1995 Office of Technology Assessment Report)

8. History is against us! What Are the Chances…?

9. Domestic Bioterrorism Attacks • 1984 • Salmonella Poisoning in Oregon • Bhagwan Shree Rajneesh of the Rajneeshee religious cult • 750 people infected, 40 hospitalized • Purpose was to influence a local election

10. Domestic Bioterrorism Attacks • 2001 • Anthrax laden letters

11. Ask Yourself…? • Did you really think there was ever a chance of an anthrax attack?

12. Smallpox

13. History of U.S. Smallpox Vaccine Recommendations • 1940’s: Last US case of smallpox • 1971: Discontinued routine vaccination of the public • 1976: Discontinued vaccination of healthcare workers • 1989: Discontinued vaccination of the military • 2003: Voluntary vaccination for first responders to a case of smallpox

14. History and Significance • Endemic smallpox was declared eradicated in 1980 by the WHO • 2 WHO approved repositories of Variola virus • CDC in Atlanta • Institute for Viral Preparations in Moscow • Extent of clandestine stockpiles in other parts of the world remains unknown • Japan considered the use of smallpox as a bioweapon in WW II

15. What is the Current Risk? • Logically, some degree of risk must exist!

16. Before You Say No, Consider This... • Military Personnel • Vaccination program has begun • Reservists currently working in hospitals may be vaccinated soon • How will their patient care activities be monitored? • What if they become ill? • Who will care for a case of Vaccinia?

17. Knowledge is Power • Know the Facts!

18. Smallpox Vaccine • Contains live Vaccinia virus • does not contain smallpox virus • Dryvax (Wyeth) vaccine • produced using calf lymph • vaccine used in the 1960’s • FDA licensed specific lots in October 2002 • only available from CDC

19. Bifurcated Needle

20. Vaccine Administration • Scarification • multiple punctures with a bifurcated needle to inoculate the superficial layers of the skin with Vaccinia • virus multiplies and causes the body to produce an immune response to Vaccinia • immunity to Vaccinia is cross-protective against smallpox

21. Clinical Response to Vaccination • 1. Papule forms (day 3-4) • 2. Vesicle forms (day 5-6) • fluid filled blister • 3. Pustule forms (day 7-9) • purulent fluid filled blister • 4. Scab forms (day 12-17) • 5. Scab falls off (day 18-28) • *The site is infectious until the scab falls off

23. Development of Immunity • 95% of primary vaccinees develop antibodies within 1-2 weeks • protection begins to fade after 5 years • Those previously vaccinated may have residual immunity, but need to be revaccinated • does not offer full protection from smallpox • may be protective against severe disease or death

24. Clinical Response to Vaccination • Major reaction – “take” • indicates viral replication has occurred and the vaccination was successful • considered to be protective • Equivocal reaction • anything other than a major reaction • indicates incorrect vaccination technique or impotent vaccine • requires revaccination • can be revaccinated 7 days after initial vaccination

25. Vaccination Complications • Most benign, even if frightening in appearance • Some serious, but treatable • Few, which are rare, can be life threatening or fatal

26. Potential Vaccine Side Effects • Symptoms usually occur about 1 week after vaccination • soreness • inflamed red ring around vaccination site • generalized weakness • swollen lymph nodes (25-50%) • fever > 100 F (2-16%) • muscle aches, headache, chills, nausea (0.3 – 37%) • fatigue • satellite lesions

27. Accidental Implantation(inadvertent inoculation) • Transfer of Vaccinia virus to other body parts or unimmunized close contacts • Common site are mucocutaneous borders (eyes, mouth, nose, rectum) • Young children at greatest risk • Lesion progression usually follows the same course as the vaccination site • Treatment usually not necessary

28. Supportive Therapy • Today’s medical treatments are improved from the ones available prior to 1971 • cidofovir as IND • No evidence exists, but these treatments may help to improve the outcomes of smallpox vaccine complications

29. Pre-Event ACIP Recommendations • Phase I: Hospital and public health response teams • vaccination for hospital response teams and public health response teams • Phase II: Other first responders - fire/police/EMS • Phase III: General public? Wait for new Acambis vaccine

30. Pre-Event Vaccination Program • Not meant to be a full scale response • Meant to be scalable if cases would occur • quick response and scale up of numbers of vaccinees • No further CDC guidelines for phase II or III plans • Plans must be flexible

31. Smallpox Healthcare Teams • Each hospital identify a group of healthcare workers who would be vaccinated • First 7-10 days, this team would be hospital based and provide care 24 hrs/day (8-12 hour shifts) • Would enable care of the first few cases presenting to a hospital • Would be able to care for the patient immediately thus minimizing further exposures

32. Order of Vaccination • First: Public Health Response Team • Will perform all vaccinations • Second: Hospital Site Care Team • Several member team to monitor the status of the Hospital Response Team Members and their vaccination sites • Third: Hospital Response Team

33. Hospital Response Team:Recommended Members • Emergency staff • Intensive care staff • General medicine staff • Medical house staff • Medical sub-specialty staff • Infection control • Phlebotomy • Respiratory therapy • Security • X-ray techs • Housekeeping and laundry

34. Hospital Response Teams • Hospital Response Team makeup: • vaccination of health care staff for purpose of caring for patients, NOT for protecting all healthcare workers • vaccinees have a responsibility to provide care if a case occurs • total hospital vaccinees expected: 50-100/hospital

35. RPSLMC Hospital Response Team • Physicians • Emergency 6 • ID: Adult 3 • ID: Peds 1 • Critical Care: Adult 6 • Critical Care: Peds 1 • Psychiatrist 1 • Other 7 • _______________________ • Total 25

36. RPSLMC Hospital Response Team • Nurses • Emergency 20 • Critical Care: Adult 20 • Critical Care: Peds 2 • Infection Control 3 • Other 10 • _______________________ • Total 55 • _______________________ • Grand Total 80

37. RPSLMC Hospital Response Team • Miscellaneous • Site Care Team 5 • Respiratory 2 • Security 5 • HVAC Technician 1 • Radiology 2 • Housekeeping 4 • Mortuary 1 • _______________________ • Total 20 • _______________________ • Grand Total 100

38. Key to a Safe Vaccination Program • Thorough screening for contraindications to eliminate individuals who are ineligible to receive the vaccine

39. Contraindications in a Pre-Event Setting • Pregnancy or breast feeding • Immunodeficiency • HIV/AIDS • cancer • Immunosuppressive therapies • cancer treatment • organ transplant maintenance • long-term steroid therapy • prednisone: 2 mg/kg/day or 20 mg/day for 14 days or longer

40. Contraindications in a Pre-Event Setting • Eczema / atopic dermatitis • healed or active • Vaccine component allergy • neomycin • streptomycin • polymyxin • tetracycline • Eye disease of conjunctiva or cornea • pruritic lesions • florid inflammation

41. Contraindications in a Pre-Event Setting • Extensive skin diseases • (until the condition resolves) • acne • burns • wounds • recent incisions • impetigo • contact dermatitis

42. Contraindications in a Pre-Event Setting • Household Contact with Contraindication • Risk of accidental inoculation of household contacts exists until the scab falls off • immunocompromised • eczema • Infants <1 year (under evaluation) • Should defer immunization in pre-event setting

44. Logistics • Hospital Response Team phase-in • designate a small proportion (20-30%) for first round to gain experience in post-vaccination management • stagger HCW within an individual unit by ~three weeks

45. Hospital Responsibilities • Participating hospitals will need to: • provide pre-program education • identify their hospital response team • evaluation and treatment of adverse events • pre-shift, daily management of vaccination site until scab off • assess dressings, change dressing as needed • assess site for local reactions and for vaccine take • evaluation of vaccination ‘takes’ and reporting to public health authorities

46. Resources • www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm • Rush specific information email: • <Dino_Rumoro@rush.edu>